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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namestent, coronary
Generic Namestent, coronary
26531 ynez road, building g
mailing p.o. 9018
temecula, CA 92590-9018
PMA NumberP000011
Date Received02/25/2000
Decision Date09/29/2000
Withdrawal Date 09/05/2014
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 01M-0055
Notice Date 03/09/2001
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the biodivysio(tm) as pc (phosphorylcholine) coated stent and delivery system. The device is intended for use in subjects with symptomatic ischemic heart disease due to de novo native coronary artery lesions (length <= 25 mm) with a reference vessel diameter ranging from >= 3. 0 mm to <= 4. 0 mm and intended to improve coronary luminal diameter. Long term outcome (beyond six months) for this permanent implant is unknown at present.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010